生物仿制药
实验设计
析因实验
设计质量
响应面法
分式析因设计
效价
计算机科学
合理设计
中心组合设计
设计-专家
数学
工程类
生物技术
统计
机器学习
生物
运营管理
抗体
遗传学
免疫学
下游(制造业)
作者
Vinay Rewaria,Mahendran Botlagunta,Pardhasaradhi Mathi
出处
期刊:Research Journal of Biotechnology
[World Researchers Associations]
日期:2023-08-15
卷期号:18 (9): 137-146
标识
DOI:10.25303/1809rjbt1370146
摘要
Selection of a suitable basal media, feed, feeding strategy and glycan structures has a pivotal role during the process development and optimization of monoclonal antibodies. Instead of using one-factor-at-time approach or classical approach for media and feed selection, a DoE approach was implemented. A Simplex centroid mixture design was applied to identify the suitable media/media combinations by evaluating cell growth and productivity followed by a full factorial design for screening of the best suitable feed that enhanced the productivity. Optimization of the process was performed using Response surface methodology with central composite design to determine the optimum interaction between the selected media and feeds. Statistically designed experiments were performed to determine the factors influencing glycan. Uridine, MnCl2 and galactose were added as per the factorial design for evaluating their effect on modulating glycosylation. Prediction of the best combination was made with the maximum response titer by Design-Expert software 12.0. A threefold increase in titer (1909 mg/L) and significant improvement in glycosylation were obtained by statistical approach.
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